Polymerase Chain Reaction and Enzyme-Linked Immunosorbent Assay as Diagnostic Tools for Detection of Hepatitis B Virus Infection, KHMC Experience

Objective: To compare serological and molecular assays for detection hepatitis B virus infection. Methods: A total of two hundreds patient were included with age range between 20 years and 60 years. Samples were obtained to detect serological markers of HBV infection using Enzyme linked immunosorbent assay (ELISA) and for HBV DNA quantitation through performing real time polymerase chain reaction (PCR). Results: Of two hundreds samples tested by ELISA for HBsAg, 186 (93%) were positive and 14 (7%) samples were negative, the results had been confirmed by PCR where 1 sample showed false positive results and 2 false negative. The specificity, sensitivity, positive predictive value, and negative predictive value for ELISA were calculated: 92%, 99%, 99%, and 86% respectively. Conclusion: ELISA is a reliable and relatively not expensive method for detection HBV, though PCR quantitation represents the gold standard assay for this purpose. Combining both methods in clinical practice ensure applying best laboratory practice if enough resources are available.